Early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy: a multicentre double-blind pilot randomised controlled trial

Author:

Garegrat ReemaORCID,Londhe Atul,Manerkar Swati,Fattepur Sudhindrashayana,Deshmukh Laxmikant,Joshi Amol,Chandriah Savitha,Kariyappa Mallesh,Devadas Sahana,Ethirajan Theranirajan,Srivasan Kalaivani,Kamalarathnam Chinnathambi,Balachandran Anitha,Krishnan Elango,Sahayaraj Deepthy,Bandiya PrathikORCID,Shivanna Niranjan,Burgod ConstanceORCID,Thayyil Ashwini,Alocious Annie,Lanza Marianna,Muraleedharan Pallavi,Pant StutiORCID,Venkateswaran Harini,Morales Maria MorenoORCID,Montaldo PaoloORCID,Krishnan Vaisakh,Kalathingal Thaslima,Joshi Anagha Rajeev,Vare Ajay,Patil G C,Satyanathan Babu Peter,Hapat Pavan,Deshmukh Abhishek,Shivarudhrappa Indramma,Annayappa Manjesh Kurupalya,Baburaj Mythili,Muradi Christina,Fernandes Esprance,Thale Nishad,Jahan Ismat,Shahidullah Mohammed,Choudhury Sadeka Moni,Dey Sanjoy Kumer,Neogi Sutapa B,Banerjee Rupsa,Rameh Vanessa,Alobeidi Farah,Grant Ellen,Juul Sandra E,Wilson Martin,Vita Enrico De,Pressler Ronit,Bassett Paul,Shankaran SeethaORCID,Thayyil Sudhin

Abstract

ObjectiveTo examine the feasibility of early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy (HIE).DesignDouble-blind pilot randomised controlled trial.SettingEight neonatal units in South Asia.PatientsNeonates (≥36 weeks) with moderate or severe HIE admitted between 31 December 2022 and 3 May 2023.InterventionsErythropoietin (500 U/kg daily) or to the placebo (sham injections using a screen) within 6 hours of birth and continued for 9 days. MRI at 2 weeks of age.Main outcomes and measuresFeasibility of randomisation, drug administration and assessment of brain injury using MRI.ResultsOf the 154 neonates screened, 56 were eligible; 6 declined consent and 50 were recruited; 43 (86%) were inborn. Mean (SD) age at first dose was 4.4 (1.2) hours in erythropoietin and 4.1 (1.0) hours in placebo. Overall mortality at hospital discharge occurred in 5 (19%) vs 11 (46%) (p=0.06), and 3 (13%) vs 9 (40.9%) (p=0.04) among those with moderate encephalopathy in the erythropoietin and placebo groups. Moderate or severe injury to basal ganglia, white matter and cortex occurred in 5 (25%) vs 5 (38.5%); 14 (70%) vs 11 (85%); and 6 (30%) vs 2 (15.4%) in the erythropoietin and placebo group, respectively. Sinus venous thrombosis was seen in two (10%) neonates in the erythropoietin group and none in the control group.ConclusionsBrain injury and mortality after moderate or severe HIE are high in South Asia. Evaluation of erythropoietin monotherapy using MRI to examine treatment effects is feasible in these settings.Trial registration numberNCT05395195.

Funder

Thrasher Research Fund

Publisher

BMJ

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